Colorectal NeoplasmsSTTELSNCT05113134
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
A study testing Transvaginal natural orifice specimen extraction (NOSE) in people with Colorectal Neoplasms and Urologic Neoplasms, run by Seoul National University Bundang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Urologic Neoplasms, Gastrointestinal Neoplasms
- What is being tested?
- Transvaginal natural orifice specimen extraction (NOSE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 24 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Transvaginal natural orifice specimen extraction (NOSE)
- Keywords
- natural orifice specimen extraction, laparoscopic surgery, transvaginal, Female
- Medical subject headings
- Colorectal Neoplasms, Urologic Neoplasms, Gastrointestinal Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal natural orifice specimen extraction (NOSE)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal natural orifice specimen extraction (NOSE) | Experimental | 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 Receives: Procedure: Transvaginal natural orifice specimen extraction (NOSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
Secondary outcomes (1)
Female Sexual Function Index (FSFI) questionnaire
Sexual function assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start2 Mar 2015
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113134
- Sponsor's protocol ID
- SNUBH B-1411-276-005
- Acronym
- STTELS
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31580003Park 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.
PubMed 29333423Guan 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.
PubMed 30792863Hwang 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.
PubMed 36309743
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)
- ClinicalTrials.gov ID
- NCT05113134
- Acronym / sponsor ID
- STTELS / SNUBH B-1411-276-005
- Keywords
- natural orifice specimen extraction, laparoscopic surgery, transvaginal, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal natural orifice specimen extraction (NOSE) | Experimental | Procedure: 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Transvaginal natural orifice specimen extraction (NOSE) |
Primary outcome
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.
1 secondary outcome
Female Sexual Function Index (FSFI) questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Results publication: PubMed 31580003Soyman 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 publication: PubMed 29333423Park 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 publication: PubMed 30792863Guan 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.
- Derived from this study: PubMed 36309743Hwang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal natural orifice specimen extraction (NOSE) in people with Colorectal Neoplasms and Urologic Neoplasms, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113134, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.