Natural Orifice Specimen Extraction in Sigmoid Volvulus

• Sponsor: Dr. Ersin Arslan Education and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04740619
• Collaborator: Inonu University (Other)
• Enrollment: 8
• Location: 1
• Actual Duration (Months): 36.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mortality; Morbidity	Procedure: Natural Orifice Specimen Extraction

Detailed Description

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. The documents of patients who were operated on for sigmoid volvulus between 2018 and 2019 were retrospectively reviewed. Patients who had been used transanal for specimen extraction by elective laparoscopic sigmoid colon resection were included in the study. Patients' gender, age, comorbidity, operation time, operative difficulties, complications, length of stay, and mortality findings were analyzed. Laparoscopic sigmoid resection and transanal specimen removal were performed in eight patients. Specimen extraction surgery from the natural hole is increasingly preferred. the investigators think that natural hole surgery can be performed more easily and reliably in sigmoid volvulus due to the large diameter of the colon.

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Natural Orifice Specimen Extraction in Sigmoid Volvulus Patients
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 15, 2020
• Actual Study Completion Date: Jan 20, 2021

Outcome Measures

Primary Outcome Measures

1. mortality [1 year]

   mortality after this procedure

2. morbidity [through study completion, an average of 1 year]

   morbidity after this procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• transanal for specimen extraction by elective laparoscopic sigmoid colon resection

Exclusion Criteria:

• emergency surgery

• conventional open sigmoid resection

• conventional laparoscopic sigmoid resection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Ersin Arslan Training and Resource Hospital	Gaziantep		Turkey

Sponsors and Collaborators

• Dr. Ersin Arslan Education and Training Hospital
• Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ufuk Uylas, Primary investigator, Dr. Ersin Arslan Education and Training Hospital
• ClinicalTrials.gov Identifier: NCT04740619
• Other Study ID Numbers: 2020/178
• First Posted: Feb 5, 2021
• Last Update Posted: Feb 5, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ufuk Uylas, Primary investigator, Dr. Ersin Arslan Education and Training Hospital: colon; volvulus; natural orifice; laparoscopy; sigmoid
• Additional relevant MeSH terms: Intestinal Volvulus

Study Results

No Results Posted as of Feb 5, 2021