NCT04740619

Brief Summary

Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 1, 2021

Last Update Submit

February 4, 2021

Conditions

MortalityMorbidity

Keywords

colonvolvulusnatural orificelaparoscopysigmoid

Outcome Measures

Primary Outcomes (2)

  • mortality

    mortality after this procedure

    1 year

  • morbidity

    morbidity after this procedure

    through study completion, an average of 1 year

Interventions

Natural Orifice Specimen ExtractionPROCEDURE

Natural Orifice Specimen Extraction via transanal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

sigmoid volvulus patients

You may qualify if:

  • transanal for specimen extraction by elective laparoscopic sigmoid colon resection

You may not qualify if:

  • emergency surgery
  • conventional open sigmoid resection
  • conventional laparoscopic sigmoid resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ersin Arslan Training and Resource Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intestinal Volvulus

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesTorsion AbnormalityPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

January 1, 2018

Primary Completion

January 15, 2020

Study Completion

January 20, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)