Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)
Primary Purpose
Colorectal Neoplasms, Urologic Neoplasms, Gastrointestinal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transvaginal natural orifice specimen extraction (NOSE)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring natural orifice specimen extraction, laparoscopic surgery, transvaginal, Female
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transvaginal natural orifice specimen extraction (NOSE)
Arm Description
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
Outcomes
Primary Outcome Measures
Patient and Observer Scar Assessment Scale (POSAS)
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
Sexual function assessment
Full Information
NCT ID
NCT05113134
First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05113134
Brief Title
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
Acronym
STTELS
Official Title
A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
July 24, 2020 (Actual)
Study Completion Date
July 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Urologic Neoplasms, Gastrointestinal Neoplasms, Neoplasms by Site
Keywords
natural orifice specimen extraction, laparoscopic surgery, transvaginal, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transvaginal natural orifice specimen extraction (NOSE)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Transvaginal natural orifice specimen extraction (NOSE)
Intervention Description
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
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI) questionnaire
Description
Sexual function assessment
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31580003
Citation
Soyman Z, Kelekci S, Aydogmus S, Demirel E, Ekmekci E. Transabdominal versus transvaginal specimen extraction in mini-laparoscopic surgery. J Obstet Gynaecol Res. 2019 Dec;45(12):2400-2406. doi: 10.1111/jog.14134. Epub 2019 Oct 3.
Results Reference
result
PubMed Identifier
29333423
Citation
Park JS, Kang H, Park SY, Kim HJ, Lee IT, Choi GS. Long-term outcomes after Natural Orifice Specimen Extraction versus conventional laparoscopy-assisted surgery for rectal cancer: a matched case-control study. Ann Surg Treat Res. 2018 Jan;94(1):26-35. doi: 10.4174/astr.2018.94.1.26. Epub 2017 Dec 28.
Results Reference
result
PubMed Identifier
30792863
Citation
Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.
Results Reference
result
PubMed Identifier
36309743
Citation
Hwang WY, Suh DH, Lee S. Cosmesis and feasibility of transvaginal natural orifice Specimen extraction (NOSE) for large organ specimen: a prospective pilot study. BMC Urol. 2022 Oct 29;22(1):165. doi: 10.1186/s12894-022-01114-4.
Results Reference
derived
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Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
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