Joris Jan Harlaar

Small bites versus large bites for closure of abdominal midline incisions (STITCH): A double-blind, multicentre, randomised controlled trial

BACKGROUND Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions. METHODS We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052. FINDINGS Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31-0·87; p=0·0131). Rates of adverse events did not differ significantly between groups. INTERPRETATION Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions. FUNDING Erasmus University Medical Center and Ethicon.

Small stitches with small suture distances increase laparotomy closure strength.

BACKGROUND There is no conclusive evidence which size of suture stitches and suture distance should be used to prevent burst abdomen and incisional hernia. METHODS Thirty-eight porcine abdominal walls were removed immediately after death and divided into 2 groups: A and B (N = 19 each). Two suturing methods using double-loop polydioxanone were tested in 14-cm midline incisions: group A consisted of large stitches (1 cm) with a large suture distance (1 cm), and group B consisted of small stitches (.5 cm) with a small suture distance (.5 cm). RESULTS The geometric mean tensile force in group B was significantly higher than in group A (787 N vs 534 N; P = .006). CONCLUSIONS Small stitches with small suture distances achieve higher tensile forces than large stitches with large suture distances. Therefore, small stitches may be useful to prevent the development of a burst abdomen or an incisional hernia after midline incisions.

Blood transfusions and prognosis in colorectal cancer: long-term results of a randomized controlled trial.

Objective:Perioperative blood transfusions may adversely affect survival in patients with colorectal malignancy, although definite proof of a causal relationship has never been reported.Background:We report the long-term outcomes of a randomized controlled trial performed between 1986 and 1991 to co

A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions

BackgroundThe median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure.Methods/DesignThe STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life.A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratios are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure.ConclusionThe STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.Trial registrationClinicaltrials.gov NCT01132209

Force sensing in surgical sutures

The tension in a suture is an important factor in the process of wound healing. If there is too much tension in the suture, the blood flow is restricted and necrosis can occur. If the tension is too low, the incision opens up and cannot heal properly. The purpose of this paper is to describe the design and evaluation of the Stitch Force (SF) sensor and the Hook-In Force (HIF) sensor. These sensors were developed to measure the force on a tensioned suture inside a closed incision and to measure the pulling force used to close the incision. The accuracy of both sensors is high enough to determine the relation between the force in the thread of a stitch and the pulling force applied on the suture by the physician. In a pilot study, a continuous suture of 7 stitches was applied on the fascia of the abdominal wall of multiple pigs to study this relationship. The results show that the max force in the thread of the second stitch drops from 3 (SD 1.2) to 1 (SD 0.3) newton after the 4th stitch was placed. During placement of the 5th, 6th and 7th stitch, the force in the 2nd stitch was not influenced anymore. This study indicates that in a continuous suture the force in the thread remains constant up to more than 3 stiches away from the pulled loose end of the suture. When a force feedback tool is developed specially for suturing in surgery on patients, the proposed sensors can be used to determine safety threshold for different types of tissue and sutures.

Transorale endoskopische Thyreoidektomie

ZusammenfassungHintergrundDas Zugangstrauma bei der Thyreoidektomie wurde durch die Entwicklung minimal-invasiver Verfahren verringert. Extrazervikale Zugänge haben zwar die sichtbare Narbe verlagert, sind aber aufgrund der Dissektionen maximal-invasiv. Daher soll mit dem transoralen Zugang zur Thyreoidektomie ein auf das Notwendige reduzierter minimal-invasiver Zugang anhand anatomischer Präparationsebenen etabliert werden.Material und MethodenPräklinisch erfolgten Dissektionen an 3 humanen Präparaten zur Identifikation „sicherer“ Regionen der vorderen Halsregion sowie der Submandibularloge. Die Mundbodenregion wurde auf relevante vaskuläre und nervale Strukturen hin untersucht. Die endoskopische minimal-invasive Thyreoidektomie erfolgte an 5 weiteren Präparaten mit anschließender Dissektion.ErgebnisseFür einen sicheren Zugang wurde ein sublingual in der Mittellinie platzierter Optiktrokar eingesetzt. Die Schilddrüsenregion war ohne Tangierung relevanter vaskulärer oder neuraler Strukturen zu erreichen. Zwei Arbeitstrokare wurden im Mundvorhof positioniert. Zugangs- und Präparationsebene liegen subplatysmal und somit in einer avaskulären Gleitschicht. Auf diese Weise kann das Operationsgebiet schnell, einfach und sicher erreicht werden.SchlussfolgerungMinimale Invasivität, anatomiegerechter Zugang und schichtgerechtes Arbeiten bilden die Rationale für einen transoralen Zugang zur Schilddrüsenloge. Es konnten anhand anatomischer Dissektionen die Grundlagen einer weiteren Prozedur im Rahmen der „natural orifice surgery“ (NOS) gezeigt werden.AbstractBackgroundSurgical access trauma in thyroidectomy has been minimized by the adoption of minimally invasive techniques. Extracervical approaches moved the incision lines outside of the visible neck region. However, because of the extensive dissection they no longer comply with the term minimally invasive. Therefore, our goal was to reduce the access trauma and establish a non-traumatic approach according to surgical planes for endoscopic minimally invasive thyroidectomy: the transoral approach.Material and methodsIn a preclinical investigation anatomical dissection was performed on three human cadavers to visualize anatomical relationships and identify safe zones of access to the anterior neck and the submandibular regions. The investigation focused on relevant vascular and neural structures in the floor of mouth. Endoscopic minimally invasive thyroidectomy was additionally performed in five specimens with anatomical dissections for the evaluation of collateral damage.ResultsFor a safe approach the optic trocar can be placed sublingually in the midline as there are no relevant vascular or neural structures on the way to the thyroid region. The working trocars can be placed bilaterally in the oral vestibule behind the canine teeth. In this way access and dissection plane are placed directly in an avascular subplatysmal area and the pretracheal working space can be reached easily, safe and fast.ConclusionsMinimum impact and a gentle dissection according to anatomical planes are the rational for the transoral route to the thyroid gland. Thus based on anatomical dissections the foundations of a novel procedure in the context of natural orifice surgery (NOS) could be established.BACKGROUND Surgical access trauma in thyroidectomy has been minimized by the adoption of minimally invasive techniques. Extracervical approaches moved the incision lines outside of the visible neck region. However, because of the extensive dissection they no longer comply with the term minimally invasive. Therefore, our goal was to reduce the access trauma and establish a non-traumatic approach according to surgical planes for endoscopic minimally invasive thyroidectomy: the transoral approach. MATERIAL AND METHODS In a preclinical investigation anatomical dissection was performed on three human cadavers to visualize anatomical relationships and identify safe zones of access to the anterior neck and the submandibular regions. The investigation focused on relevant vascular and neural structures in the floor of mouth. Endoscopic minimally invasive thyroidectomy was additionally performed in five specimens with anatomical dissections for the evaluation of collateral damage. RESULTS For a safe approach the optic trocar can be placed sublingually in the midline as there are no relevant vascular or neural structures on the way to the thyroid region. The working trocars can be placed bilaterally in the oral vestibule behind the canine teeth. In this way access and dissection plane are placed directly in an avascular subplatysmal area and the pretracheal working space can be reached easily, safe and fast. CONCLUSIONS Minimum impact and a gentle dissection according to anatomical planes are the rational for the transoral route to the thyroid gland. Thus based on anatomical dissections the foundations of a novel procedure in the context of natural orifice surgery (NOS) could be established.

[Transoral endoscopic thyroidectomy : Part 2: Surgical technique].

BACKGROUND Thyroid surgery is one of the newest fields for application of video-assisted surgery. The majority of approaches must choose between optimizing cosmetic results by hiding scars in the chest and axillary region while maximizing tissue dissection and post-operative pain versus having a visible cervical scar with minimal tissue dissection. In an effort to minimize surgical trauma and to achieve an optimal cosmetic result we investigated the transoral approach to the thyroid. MATERIAL AND METHODS In three cadavers the safety and reproducibility to access and resect the thyroid gland were assessed according to a defined road map. The surgical procedure itself was performed on two further cadavers with the help of one 5 mm trocar and two 3 mm trocars which were introduced bilaterally through the floor of mouth and the oral vestibule. A subplatysmal working space was created by blunt dissection and CO(2) insufflation to a pressure of 4-6 mmHg. Division of the median raphe of the neck muscles was followed by exposure of the thyroid gland. In the next step the isthmus was transected, the upper pole arteries dissected and divided and the medial thyroid vein cut close to the gland. Thyroid resection was performed from cranial to caudal and the specimen was removed transorally through the 5 mm midline incision. RESULTS Description of landmarks of the surgical steps and dissection of defined anatomic structures could be achieved. Unilateral subtotal thyroid resection could be successfully performed without any additional skin incisions in 59 min. Postoperatively performed anatomical dissection showed intact surrounding structures. CONCLUSION Our results demonstrate the feasibility and safety of a transoral access for thyroidectomy. In comparison to other minimally invasive thyroidectomy access procedures, the transoral approach is minimally invasive and at the same time cosmetically optimal.

Effects of New Anti-Adhesion Polyvinyl Alcohol Gel on Healing of Colon Anastomoses in Rats

BACKGROUND Adhesions follow abdominal surgery with an incidence as high as 95%, resulting in invalidating complications such as bowel obstruction, female infertility, and chronic pain. Searches have been performed for a safe and effective adhesion barrier; however, such barriers have impaired anastomotic site healing. The primary aim of this study was to investigate the effect of a new adhesion barrier, polyvinyl alcohol gel, on healing of colonic anastomoses using a rat model. METHODS Thirty-two Wistar rats were divided in two groups. In all animals, an anastomosis was constructed in the ascending colon. The first group received no adhesion barrier, whereas in the second group, 2 mL of polyvinyl alcohol gel (A-Part Gel(®); Aesculap AG, Tuttlingen, Germany) was applied circularly around the anastomosis. All animals were sacrificed on the seventh post-operative day, and the abdomen was inspected for signs of anastomotic leakage. The anastomotic bursting pressure, the adhesions around the anastomosis, and the collagen content of the excised anastomosis were measured. RESULTS No significant differences were observed between the two groups in the incidence of anastomotic leakage, the anastomotic bursting pressure (p=0.08), or the collagen concentration (p=0.91). No significant reduction in amount of adhesions was observed in the rats receiving polyvinyl alcohol gel. CONCLUSIONS This experimental study showed no significant differences in anastomotic leakage, anastomotic bursting pressure, or collagen content of the anastomosis when using the adhesion barrier polyvinyl alcohol around colonic anastomoses. The barrier did not prevent adhesion formation.

[Transoral endoscopic thyroidectomy. Part 1: rationale and anatomical studies].

ZusammenfassungHintergrundDas Zugangstrauma bei der Thyreoidektomie wurde durch die Entwicklung minimal-invasiver Verfahren verringert. Extrazervikale Zugänge haben zwar die sichtbare Narbe verlagert, sind aber aufgrund der Dissektionen maximal-invasiv. Daher soll mit dem transoralen Zugang zur Thyreoidektomie ein auf das Notwendige reduzierter minimal-invasiver Zugang anhand anatomischer Präparationsebenen etabliert werden.Material und MethodenPräklinisch erfolgten Dissektionen an 3 humanen Präparaten zur Identifikation „sicherer“ Regionen der vorderen Halsregion sowie der Submandibularloge. Die Mundbodenregion wurde auf relevante vaskuläre und nervale Strukturen hin untersucht. Die endoskopische minimal-invasive Thyreoidektomie erfolgte an 5 weiteren Präparaten mit anschließender Dissektion.ErgebnisseFür einen sicheren Zugang wurde ein sublingual in der Mittellinie platzierter Optiktrokar eingesetzt. Die Schilddrüsenregion war ohne Tangierung relevanter vaskulärer oder neuraler Strukturen zu erreichen. Zwei Arbeitstrokare wurden im Mundvorhof positioniert. Zugangs- und Präparationsebene liegen subplatysmal und somit in einer avaskulären Gleitschicht. Auf diese Weise kann das Operationsgebiet schnell, einfach und sicher erreicht werden.SchlussfolgerungMinimale Invasivität, anatomiegerechter Zugang und schichtgerechtes Arbeiten bilden die Rationale für einen transoralen Zugang zur Schilddrüsenloge. Es konnten anhand anatomischer Dissektionen die Grundlagen einer weiteren Prozedur im Rahmen der „natural orifice surgery“ (NOS) gezeigt werden.AbstractBackgroundSurgical access trauma in thyroidectomy has been minimized by the adoption of minimally invasive techniques. Extracervical approaches moved the incision lines outside of the visible neck region. However, because of the extensive dissection they no longer comply with the term minimally invasive. Therefore, our goal was to reduce the access trauma and establish a non-traumatic approach according to surgical planes for endoscopic minimally invasive thyroidectomy: the transoral approach.Material and methodsIn a preclinical investigation anatomical dissection was performed on three human cadavers to visualize anatomical relationships and identify safe zones of access to the anterior neck and the submandibular regions. The investigation focused on relevant vascular and neural structures in the floor of mouth. Endoscopic minimally invasive thyroidectomy was additionally performed in five specimens with anatomical dissections for the evaluation of collateral damage.ResultsFor a safe approach the optic trocar can be placed sublingually in the midline as there are no relevant vascular or neural structures on the way to the thyroid region. The working trocars can be placed bilaterally in the oral vestibule behind the canine teeth. In this way access and dissection plane are placed directly in an avascular subplatysmal area and the pretracheal working space can be reached easily, safe and fast.ConclusionsMinimum impact and a gentle dissection according to anatomical planes are the rational for the transoral route to the thyroid gland. Thus based on anatomical dissections the foundations of a novel procedure in the context of natural orifice surgery (NOS) could be established.BACKGROUND Surgical access trauma in thyroidectomy has been minimized by the adoption of minimally invasive techniques. Extracervical approaches moved the incision lines outside of the visible neck region. However, because of the extensive dissection they no longer comply with the term minimally invasive. Therefore, our goal was to reduce the access trauma and establish a non-traumatic approach according to surgical planes for endoscopic minimally invasive thyroidectomy: the transoral approach. MATERIAL AND METHODS In a preclinical investigation anatomical dissection was performed on three human cadavers to visualize anatomical relationships and identify safe zones of access to the anterior neck and the submandibular regions. The investigation focused on relevant vascular and neural structures in the floor of mouth. Endoscopic minimally invasive thyroidectomy was additionally performed in five specimens with anatomical dissections for the evaluation of collateral damage. RESULTS For a safe approach the optic trocar can be placed sublingually in the midline as there are no relevant vascular or neural structures on the way to the thyroid region. The working trocars can be placed bilaterally in the oral vestibule behind the canine teeth. In this way access and dissection plane are placed directly in an avascular subplatysmal area and the pretracheal working space can be reached easily, safe and fast. CONCLUSIONS Minimum impact and a gentle dissection according to anatomical planes are the rational for the transoral route to the thyroid gland. Thus based on anatomical dissections the foundations of a novel procedure in the context of natural orifice surgery (NOS) could be established.

Reply to: doi:10.1007/s00464-009-0677-y: Re: Natural orifice surgery on thyroid gland—totally transoral video-assisted thyroidectomy (TOVAT)—report of first experimental results of a new surgical method (2009 (23):1119-1120)

With great pleasure we take the opportunity to answer the comments of Drs. Paolo Miccoli, Gabriele Materazzi, and Piero Berti on our article Natural Orifice Surgery on the Thyroid Gland: Totally Transoral Video-Assisted Thyroidectomy (TOVAT): Report of the First Experimental Results of a New Surgical Method, which appeared in the May 2009 issue of Surgical Endoscopy [1]. Because our article is a multimedia report comprising a video and an abstract, it was not possible to mention more details and data dealing with this new technique. Paolo Miccoli and his colleagues raised the following concerns: