Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques

NCT03527433 | Recruiting DMC

• 1 other identifier: BIO-2017-038
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

Wound complications, increased hospital stays and post-operative morbidity are all common following abdominal surgery. Abdominal closure complications are strongly associated with the closure technique and material used. The traditional closure technique used by surgeons is placing the wide and large stitches. A randomized controlled trial done in Sweden described a new closure technique in surgeries by placing the stitches closer to each other by using narrow. The results showed lower incidence of wound infections, hernias, and wound rupture. However, the study provides low quality evidence on the benefits of this new technique since it has numerous limitations like lack of standardization of suture size, lack of proper randomization, and heterogeneity in patient eligibility which will increase result bias. There is still a need for quality evidence on the effectiveness of this new closing technique procedure at decreasing wound complications after the operation. In this trial the investigators will compare two techniques in the closure of abdominal wounds in patients undergoing abdominal surgery. The first technique will be the traditional closure technique currently used in abdominal surgery. The second technique will be using the new closure technique. The closure of abdominal wounds with small and close sutures using the new technique is expected to lower the incidence of hernia and wound complications as well as improve the quality of life of the patient. Potential candidates for the study are those who will be undergoing elective midline laparotomy at AUBMC. The patients and assessor of outcomes will be blinded and patients will be randomized to receive either the traditional or new closure operation technique. There are no anticipated risks for those participating in the study. All data and information collected will be kept confidential. Hypothesis: Closure of abdominal fascia in elective midline laparotomy incisions with small and close sutures compared to closure with conventional wide and distant sutures results in lower rates of wound rupture, incisional hernia, and wound infection, and improved quality of life. Significance: The results of this study will allow surgeons to assess the role of a new abdominal closure technique in decreasing short and long term postoperative complications, for a commonly performed procedure. This trial will generate evidence-based conclusions.

Conditions

Wound Complication

Keywords

Incisional hernia; Wound infection; Midline laparotomy

Outcome Measures

Primary Outcomes (1)

• Incisional hernia

  We will define incisional hernia according to the European Society of Hernia: "any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging". (7) Using both clinical exam and imaging if performed, these hernias will be described according to their location along the midline, size of the defect using vertical and transverse measurements, and reducibility of any protruding viscera upon lying down or following gentle pressure by the examining hand. Also, we will collect information whether the hernia is causing any pain, discomfort, decrease in mobility, or any incidence of incarceration where the hernia contents protrude and does not reduce to the abdomen upon gentle pressure.

  1 year

Secondary Outcomes (2)

• Fascial dehiscence or evisceration

  1 month postoperative

• Intervention rate for wound complications

  1 month postoperative

Other Outcomes (4)

• Wound seroma

  1 month postoperative

• Wound infection

  1 month postoperative

• Intensity of Pain

  up to 1 week

Study Arms (2)

Standard arm

NO INTERVENTION

In the standard arm, an average of one suture will be placed at each cm length of the wound, thus the number of sutures placed should be equal to the length of the wound in cm.

Intervention arm

EXPERIMENTAL

The intervention arm will undergo the alternative/new closure technique with small and close fascia sutures, where each suture will be placed only 5 mm away from the fascia edge and 5 mm apart from the adjacent fascia suture.

Procedure: New closure technique

Interventions

New closure technique PROCEDURE

In the intervention arm, an average of two sutures will be placed at each cm length of the wound, thus the number of sutures placed should be equal to at least double the length of the wound in cm.The aim is to have a ratio of 4:1 between the overall lengths of the suture to the length of the wound being closed

Also known as: Alternative closure technique

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Signed Informed Consent
• Undergoing an elective laparotomy through a midline incision
• Undergoing a midline laparoscopic procedure (midline laparoscopic extraction site)

You may not qualify if:

• Emergency surgery
• Laparotomy through an incision other than midline
• Previous midline laparotomy
• Presence of incisional or ventral hernia at time of laparotomy
• Incisional hernia repair
• Laparotomy surgery during pregnancy

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Beyrouth, Lebanon

RECRUITING

Related Publications (8)

• Leaper DJ, van Goor H, Reilly J, Petrosillo N, Geiss HK, Torres AJ, Berger A. Surgical site infection - a European perspective of incidence and economic burden. Int Wound J. 2004 Dec;1(4):247-73. doi: 10.1111/j.1742-4801.2004.00067.x.

  PMID: 16722874 BACKGROUND

• Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed). 1982 Mar 27;284(6320):931-3. doi: 10.1136/bmj.284.6320.931.

  PMID: 6279229 BACKGROUND

• Wissing J, van Vroonhoven TJ, Schattenkerk ME, Veen HF, Ponsen RJ, Jeekel J. Fascia closure after midline laparotomy: results of a randomized trial. Br J Surg. 1987 Aug;74(8):738-41. doi: 10.1002/bjs.1800740831.

  PMID: 3307992 BACKGROUND

• Rahbari NN, Knebel P, Diener MK, Seidlmayer C, Ridwelski K, Stoltzing H, Seiler CM. Current practice of abdominal wall closure in elective surgery - Is there any consensus? BMC Surg. 2009 May 15;9:8. doi: 10.1186/1471-2482-9-8.

  PMID: 19442311 BACKGROUND

• Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM. Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg. 2010 May;251(5):843-56. doi: 10.1097/SLA.0b013e3181d973e4.

  PMID: 20395846 BACKGROUND

• Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.

  PMID: 19917943 BACKGROUND

• Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.

  PMID: 19495920 BACKGROUND

• El Charif MH, Hassan Z, Hoballah J, Khalife M, Sbaity E. Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial. Trials. 2020 Jul 2;21(1):608. doi: 10.1186/s13063-020-04507-8.

  PMID: 32616017 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Wound Infection

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Infections

Study Officials

• Eman Sbaity, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Sbaity, MD

CONTACT

+(961)76-110882; es25@aub.edu.lb

Mohamad Hadi El Charif, MD

CONTACT

+961-3-170055; me209@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Surgery

Model Details: 1:1 ratio

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 17, 2018
• Study Start: October 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)