Clinical trial NCT05113134: Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
Official title: A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Urologic Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Keywords: natural orifice specimen extraction
laparoscopic surgery
transvaginal
Female
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 8 week
Secondary outcomes:
measure: Female Sexual Function Index (FSFI) questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.