Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)

November 5, 2021 updated by: Seoul National University Bundang Hospital

A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design:

This was a prospective, single center, single arm study. This clinical trial was approved by the Institutional Review Boards.

Study process:

All patients gave informed written consent after being informed of the details of the study. All participants underwent demographic and history taking, laboratory tests and a gynecological examination to determine whether specimen removal through vagina is possible. The patients who was adequate for this study were planned to perform multiport laparoscopic surgery and patients were subjected to transvaginal NOSE.

To perform transvaginal NOSE procedure, the patients were placed in the lithotomy position with Trendelenburg position. After about 1-2cm incision at the posterior vaginal fornix, endopouch was introduced into the abdominal cavity through vaginal incision site. The specimen was placed inside a endopouch and removed through vagina. Closure of vaginal incision site was achieved by transvaginally with 2/0 absorbable suture.

During the second and third visit at 1 week and 8 week, Patient and Observer Scar Assessment Scale (POSAS) was performed to assess cosmetic outcomes of scar. Subjects with sexual activity carried out Female Sexual Function Index (FSFI) questionnaire to assess sexual function at final visit which occurred at 6 months after surgery.

Statistical analysis:

All data are summarized as means ± standard deviation or as numbers with proportions. A p < 0.05 was considered to indicate significance. Student's t-test and Mann-Whitney U test were conducted to compare continuous parametric variables and non-parametric variables, respectively.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who are accessible with vaginal approach
  • Patients scheduled for laparoscopic resection of stomach, colon, kidney and spleen for benign or malignant diseases
  • Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings

Exclusion Criteria:

  • Patients without sexual intercourse
  • Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination
  • Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history
  • Patients with abnormal cervical cancer screening tests
  • Patients scheduled to perform concomitant hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvaginal natural orifice specimen extraction (NOSE)
The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder
Procedure: Transvaginal natural orifice specimen extraction (NOSE)
Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder will undergo Transvaginal NOSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 8 week
Cosmetic outcomes of scar assessed by Patient and Observer Scar Assessment Scale (POSAS) 1 week and 8 weeks after surgery. The POSAS is the international validated scar assessment questionnaire that measures quality of the scar from the perspective of both patient and observer.
8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female Sexual Function Index (FSFI) questionnaire
Time Frame: 6 months
Sexual function assessment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

July 24, 2020

Study Completion (Actual)

July 24, 2020

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH B-1411-276-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urologic Neoplasms

Clinical Trials on Transvaginal natural orifice specimen extraction (NOSE)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe