STTELS: Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05113134

Collaborator

(none)

Enrollment

Arm

64.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Urologic Neoplasms Gastrointestinal Neoplasms Neoplasms by Site	Procedure: Transvaginal natural orifice specimen extraction (NOSE)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2015

Actual Primary Completion Date :

Jul 24, 2020

Actual Study Completion Date :

Jul 24, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient and Observer Scar Assessment Scale (POSAS) [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.

Secondary Outcome Measures

Female Sexual Function Index (FSFI) questionnaire [6 months]
Sexual function assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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