NCT07766044

Brief Summary

The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases. The patients had the abdominal wall closure performed with either a device for standardized closure or manual closure. The devices aims to secure the closure technique that is advocated by guidelines and could potentially reduce abdominal wall complications. Upholding closure quality can be cumbersome and time consuming and hence inferior closure can sometimes be associated with manual closure. Follow-up will include short term complications like wound infection and burst abdomen and one-year follow-up include a review of patients chart and CTscans performed as part of standard clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 18, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Incisional Hernia After Midline LaparotomyColorectal Cancer

Keywords

LaparotomyIncisional herniaDevice assisted closureSmall-bitesBurst abdomenWound infectionLaparotomy closure

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia at 1-year

    Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.

    1-year

Secondary Outcomes (4)

  • Wound infection

    30 days

  • Suture length to wound length ratio

    At the surgical procedure date

  • Wound dehiscence

    30 days from surgical procedure

  • Death due to abdominal wall related complication

    30 days

Other Outcomes (1)

  • Demographic data

    1 year

Study Arms (2)

Device assisted laparotomy closure

ACTIVE COMPARATOR

38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure

Device: Device assisted laparotomy closure

Manual laparotomy closure

OTHER

180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure

Behavioral: Manual laparotomy closure

Interventions

Device assisted laparotomy closureDEVICE

SutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure.

Also known as: SutureTOOL
Device assisted laparotomy closure
Manual laparotomy closureBEHAVIORAL

Standard practice of laparotomy closure using standard needle driver and curved needle

Manual laparotomy closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • Patients selected for elective surgical procedure through a midline incision due to colorectal disease

You may not qualify if:

  • Previous surgery including the midline
  • Previous hernia including the midline
  • Collagen disease
  • Disseminated disease at the time of surgery
  • Life expectancy less than 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingborg hospital

Helsingborg, Skåne County, 251 87, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsIncisional HerniaWound Infection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cohort study
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

July 18, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymized data can be shared upon request

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publication
Access Criteria
upon request

Locations

SE(1)