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The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery

The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery - The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048442
Enrollment
284
Registered
2022-08-01
Start date
2022-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patients who undergo elective gastroenterological surgery with a class II (clean-contaminated) surgical wound

Interventions

Midline abdominal wall incision closure with continuous sutures of fascia without peritoneum closure and continuous sutures of subcuticular tissue Midline abdominal wall incision closure with interr

Sponsors

Saitama Medical Center, Jichi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Scheduled to undergo elective surgery for esophagus, stomach, duodenum, jejunum, ileum, colorectal, pancreas, liver or biliary tract with a class II (clean-contaminated) surgical wound 2 Age >= 18 years old at the time of consent being obtained by non-blinded investigators. 3 Scheduled to undergo computed tomography one year after surgery 4 Written informed consent provided

Exclusion criteria

Exclusion criteria: 1 Emergency surgery 2 Under 18 years old 3 A history of midline abdominal wall incision 4 A history of abdominal incisional hernia or fascial tear 5 Identification of bacterial infection in the surgical field or the use antibiotic therapy prior to the operation. 6 Presence of a contaminated abdominal cavity due to stoma, intestinal fistula or drainage tube. 7 Open wound management for prior operation. 8 Synchronous operation for more than two targeted organs. 9 Current immunotherapy (>= 40 mg of a corticosteroid per day or azathioprine) 10 Chemotherapy within 14 days prior to surgery 11 A history of radiotherapy of the abdomen 12 Pregnancy 13 Registered for another clinical trial 14 Conditions that make the patient unsuitable for inclusion according to the judgement of non-blinded investigators.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative wound complications, including wound bleeding, hematoma, surgical site infection, seroma and wound dehiscence within 30 days after surgery, and incisional hernia within 1 year after surgery

Secondary

MeasureTime frame
Duration of abdominal wall closure and wound pain seven days after surgery

Countries

Japan

Contacts

Public ContactYuki Mizusawa

Saitama Medical Center, Jichi Medical University Department of Surgery

yuki.afterdark@gmail.com0486472111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026