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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
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    November 5, 2021
    Last Updated
    November 5, 2021
    Sponsor
    Seoul National University Bundang Hospital
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    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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