The STITCH trial: a summary

One discussion this week mentioned the STITCH trial.

Reference: Deerenberg EB, et al. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised control trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7.

Summary: Incisional hernia is a frequent complication of abdominal operations with an incidence of 10–23%, which can increase to 38% in specific risk groups. It is associated with pain and discomfort, resulting in a decreased quality of life. Incarceration and strangulation of abdominal contents can take place, for which emergency surgery is indicated, with associated morbidity and mortality. The authors (2015) estimate about 348,000 operations for incisional hernia are done every year in the US with $3.2 billion in annual associated costs.

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The impact of abdominal incisional closure techniques on rates of fascial dehiscence

Tolstrup MB, Watt SK, Gögenur I. Reduced Rate of Dehiscence After Implementation of a Standardized Fascial Closure Technique in Patients Undergoing Emergency Laparotomy. Ann Surg. 2017 Apr;265(4):821-826.

Full-text for Emory users.

RESULTS: We included 494 patients from 2014 to 2015 and 1079 patients from our historical cohort for comparison. All patients had a midline laparotomy in an emergency setting. The rate of dehiscence was reduced from 6.6% to 3.8%, P = 0.03 comparing year 2009 to 2013 with 2014 to 2015. Factors associated with dehiscence were male gender [hazard ratio (HR) 2.8, 95% confidence interval (95% CI) (1.8-4.4), P < 0.001], performance status ≥3 [HR 2.1, 95% CI (1.2-3.7), P = 0.006], cirrhosis [HR 3.8, 95% CI (1.5-9.5), P = 0.004], and retention sutures [HR 2.8, 95% CI (1.6-4.9), P < 0.000]. The 30-day mortality rate was 18.4% in the standardized group vs 22.4% in 2009 to 2013, P = 0.057 and 90-day mortality 24.2% vs 30.4%, P = 0.008.

CONCLUSION: The standardized procedure of closing the midline laparotomy by using a “small steps” technique of continuous suturing with a slowly absorbable (polydioxanone) suture material reduces the rate of fascial dehiscence.

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WARC Journal Club: STITCH Trial

Deerenberg EB, Harlaar JJ, Steyerberg EW, et al. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260.

Full-text for Emory users.

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.

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Barbed sutures: a manufacturer’s indications for use, and a study of use in anastamotic closures

One discussion this week involved the appropriate use of V-LOC sutures.

References: Davis J. Global Value Dossier for V-LOC Wound Closure Device: Technology and Surgical Applications (version 2.0). 2018 Apr 20. Germany: Coreva-Scientific

Tsukata T, et al. Use of barbed sutures in laparoscopic gastrointestinal single-layer sutures. JSLS. 2016 Jul-Sep;20(3): pii: e2016.00023. doi: 10.4293/JSLS.2016.00023.

Summary: When contemplating the best use for a technology, it helps to ask the creator, or in this case, the manufacturer. In section 2.4 (p.12) of their Global Value Dossier for V-LOC Wound Closure Device, Medtronic describes the indications for use as follows:

“Always refer to the package insert for indications and instructions for use of V-LocTM wound closure devices appropriate for your jurisdiction. Absorbable (V-LocTM 90 and 180), and nonabsorbable (V-LocTM PBT), devices are indicated for use in soft tissue approximation wherever the use of standard, non-barbed absorbable or non-absorbable sutures is appropriate, respectively. The product is contraindicated for patients with allergies to its components and should not be secured by tying surgical knots, or used with interrupted suturing patterns, or for ligating vessels or luminal structures. The technology has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic, orthopedic or microsurgery applications.”

(Davis, 2018).

In a 2016 study out of Japan, Tsukada, Kaji, Kinoshita, and Shimizu analyzed the results of 40 laparoscopic anastomoses that involved V-LOC sutures.

METHODS: Between August 2012 and March 2014, 15-cm-long barbed sutures (V-Loc 180; Covidien, Mansfield, MA, USA) were used for laparoscopic intestinal anastomoses, including intestinal hole closure for esophagojejunal and gastrojejunal anastomoses after mechanical anastomoses and gastric wall closure after partial resection.

RESULTS: 38 patients underwent 40 laparoscopic anastomoses

( 26 esophagojejunostomies; 7 gastrojejunostomies; 7 simple closure of gastric defect)

  • No cases required conversion to open surgery.
  • Two cases exhibited positive air leak test results during surgery (1 case of esophagojejunostomy and 1 case of simple closure of gastric defect)
  • Two cases of intestinal obstruction were noted; of those, one patient with postoperative intestinal paresis (grade II) was managed conservatively, and the other underwent repeat laparoscopic surgery (grade IIIb) for internal herniation unrelated to V-Loc use.
  • No postoperative complications at the anastomosis site and no surgery-related deaths were noted.

CONCLUSION: Single-layer entire-thickness running suturing with the V-Loc 180 barbed suture after stapled side-to-side intestinal anastomosis was found to be safe and feasible in the reported cases.