Single-stapled Double Purse-string Technique for Colorectal Anastomosis

NCT ID: NCT04223141

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2025-12-31

Brief Summary

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A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Detailed Description

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In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Conditions

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Colo-rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique

Group Type EXPERIMENTAL

SIA

Intervention Type PROCEDURE

As indicated by arm description

Interventions

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SIA

As indicated by arm description

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Verified cancer of the sigmoid colon
* Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
* Operation with curative intent

Exclusion Criteria

* Not legally competent and/or \< 18 years old
* Not able to comprehend information and/or give written consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helene J Würtz, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Surgeon

Flemming H Dall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Hans B Rahr, MD DMSc

Role: STUDY_DIRECTOR

Department Head

Locations

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Vejle Hospital, Department of Surgery

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SIA2020

Identifier Type: -

Identifier Source: org_study_id

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