Benign Tumor of UterusNCT06817460
A Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
A study testing Transumbilical Laparoendoscopic Single-Site Surgery and Multi-Port Laparoscopic Surgery in people with Benign Tumor of Uterus and Surgical Approaches, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS)… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Benign Tumor of Uterus, Surgical Approaches, Enhanced Recovery After Surgery
- What is being tested?
- Transumbilical Laparoendoscopic Single-Site Surgery and Multi-Port Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2025to 30 Nov 2025
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- an indication for total hysterectomy, including leiomyoma, adenomyosis, abnormal uterine bleeding, high-grade squamous intraepithelial lesion (HSIL) or endometrial intraepithelial neoplasm (EIN);
- and a thorough understanding of the risks and benefits of both TU-LESS and MPLS surgical approaches, willingness to undergo either procedure, and provision of written informed consent.
Who cannot join
- concomitant vulvar, vaginal, or appendiceal pathologies requiring concurrent surgical intervention;
- confirmed or suspected invasive malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases.
Read the detailed description
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases. Eligible patients will be randomly assigned to undergo MPLS or TU-LESS. The primary outcome is the 24-hour postoperative comprehensive ERAS compliance rate. Secondary outcomes include operative time, postoperative hemoglobin, intraoperative estimated blood loss, transfusion rate, time to first flatus, 24-hour postoperative visual analogue scale (VAS) pain score, rate of successful voiding following urinary catheter removal, and 3-month patient and observer scar assessment scale (POSAS) scores.
- Being tested
- Transumbilical Laparoendoscopic Single-Site Surgery, Multi-Port Laparoscopic Surgery
- Keywords
- hysterectomy, single-port, multi-port, enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transumbilical Laparoendoscopic Single-Site SurgeryProcedure or surgery
Total hysterectomy performed through a single incision made at the umbilicus, using specialized single-port access devices.
Multi-Port Laparoscopic SurgeryProcedure or surgery
Total hysterectomy performed through 3 to 4 small incisions in the abdomen, using conventional laparoscopic instruments and ports.
| Study group | Role | What they receive |
|---|---|---|
| Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group | Experimental | Patients undergoing total hysterectomy via transumbilical laparoendoscopic single-site surgery (TU-LESS) under standardized ERAS protocol. Perioperative management follows the same ERAS pathway as the comparator group. Receives: Procedure: Transumbilical Laparoendoscopic Single-Site Surgery |
| Multi-Port Laparoscopic Surgery (MPLS) Group | Active comparator | Patients undergoing total hysterectomy via conventional multi-port laparoscopic surgery (MPLS) under standardized ERAS protocol. This serves as the active control representing current standard surgical practice. Receives: Procedure: Multi-Port Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively
The proportion of patients achieving all five predefined ERAS criteria simultaneously within 24 hours post-surgery: (1) oral liquid intake tolerated; (2) first flatus passed; (3) spontaneous urination after catheter removal; (4) ambulation; and (5) Visual Analogue Scale (VAS) pain score ≤ 3. Failure to meet any single criterion within 24 hours is defined as non-achievement. This is a composite primary outcome measure.
Measured: Within 24 hours postoperatively
Secondary outcomes (9)
Postoperative Hemoglobin Level
Hemoglobin concentration measured on the first postoperative morning (Day 1).
Measured: Postoperative Day 1
Hemoglobin Decrease
Calculated as preoperative hemoglobin minus postoperative Day 1 hemoglobin.
Measured: From baseline to Postoperative Day 1
Estimated Blood Loss (EBL)
Intraoperative blood loss volume estimated by the attending surgeon.
Measured: Intraoperative
Blood Transfusion Rate
Proportion of patients receiving allogeneic or autologous blood transfusion during or after surgery.
Measured: Intraoperative to 7 days postoperatively
Time to First Flatus
Time interval from the end of surgery to the first passage of flatus.
Measured: From end of surgery to event (within 7 days)
Rate of successful voiding following urinary catheter removal
Rate of successful voiding following urinary catheter removal
Measured: From catheter removal to event (within 7 days)
24-Hour Postoperative VAS Pain Score
Pain intensity assessed using the Visual Analogue Scale (0-10 cm, 0 = no pain, 10 = worst possible pain) at 24 hours postoperatively.
Measured: At 24 hours postoperatively
Patient Scar Assessment Scale (PSAS)
Patient-reported scar evaluation using the PSAS component of the POSAS, assessing six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item scored 1-10. Total score ranges 6-60 (higher = worse scar).
Measured: At 3 months postoperatively
Observer Scar Assessment Scale (OSAS)
Clinician-rated scar evaluation using the OSAS component of the POSAS, assessing six items: vascularity, pigmentation, thickness, relief, pliability, and surface area. Each item scored 1-10. Total score ranges 6-60 (higher = worse scar).
Measured: At 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start12 Feb 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Tumor of UterusStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817460
- Sponsor's protocol ID
- 2024105
- Status last verified
- Feb 2025
- First submitted
- 21 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
- ClinicalTrials.gov ID
- NCT06817460
- Acronym / sponsor ID
- 2024105
- Keywords
- hysterectomy, single-port, multi-port, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 10 Feb 2025 (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.
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases.
Detailed description
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases. Eligible patients will be randomly assigned to undergo MPLS or TU-LESS. The primary outcome is the 24-hour postoperative comprehensive ERAS compliance rate. Secondary outcomes include operative time, postoperative hemoglobin, intraoperative estimated blood loss, transfusion rate, time to first flatus, 24-hour postoperative visual analogue scale (VAS) pain score, rate of successful voiding following urinary catheter removal, and 3-month patient and observer scar assessment scale (POSAS) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group | Experimental | Procedure: Transumbilical Laparoendoscopic Single-Site SurgeryPatients undergoing total hysterectomy via transumbilical laparoendoscopic single-site surgery (TU-LESS) under standardized ERAS protocol. Perioperative management follows the same ERAS pathway as the comparator group. |
| Multi-Port Laparoscopic Surgery (MPLS) Group | Active comparator | Procedure: Multi-Port Laparoscopic SurgeryPatients undergoing total hysterectomy via conventional multi-port laparoscopic surgery (MPLS) under standardized ERAS protocol. This serves as the active control representing current standard surgical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years;
- an indication for total hysterectomy, including leiomyoma, adenomyosis, abnormal uterine bleeding, high-grade squamous intraepithelial lesion (HSIL) or endometrial intraepithelial neoplasm (EIN);
- and a thorough understanding of the risks and benefits of both TU-LESS and MPLS surgical approaches, willingness to undergo either procedure, and provision of written informed consent.
Key exclusion criteria (2 listed)
- concomitant vulvar, vaginal, or appendiceal pathologies requiring concurrent surgical intervention;
- confirmed or suspected invasive malignancy.
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 |
|---|---|---|
| Transumbilical Laparoendoscopic Single-Site SurgeryTotal hysterectomy performed through a single incision made at the umbilicus, using specialized single-port access devices. | Procedure or surgery | Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group |
| Multi-Port Laparoscopic SurgeryTotal hysterectomy performed through 3 to 4 small incisions in the abdomen, using conventional laparoscopic instruments and ports. | Procedure or surgery | Multi-Port Laparoscopic Surgery (MPLS) Group |
Primary outcome
Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively
Time frame: Within 24 hours postoperatively
The proportion of patients achieving all five predefined ERAS criteria simultaneously within 24 hours post-surgery: (1) oral liquid intake tolerated; (2) first flatus passed; (3) spontaneous urination after catheter removal; (4) ambulation; and (5) Visual Analogue Scale (VAS) pain score ≤ 3. Failure to meet any single criterion within 24 hours is defined as non-achievement. This is a composite primary outcome measure.
9 secondary outcomes
Postoperative Hemoglobin Level
Time frame: Postoperative Day 1
Hemoglobin Decrease
Time frame: From baseline to Postoperative Day 1
Estimated Blood Loss (EBL)
Time frame: Intraoperative
Blood Transfusion Rate
Time frame: Intraoperative to 7 days postoperatively
Time to First Flatus
Time frame: From end of surgery to event (within 7 days)
Rate of successful voiding following urinary catheter removal
Time frame: From catheter removal to event (within 7 days)
24-Hour Postoperative VAS Pain Score
Time frame: At 24 hours postoperatively
Patient Scar Assessment Scale (PSAS)
Time frame: At 3 months postoperatively
Observer Scar Assessment Scale (OSAS)
Time frame: At 3 months postoperatively
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 15 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transumbilical Laparoendoscopic Single-Site Surgery and Multi-Port Laparoscopic Surgery in people with Benign Tumor of Uterus and Surgical Approaches, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 2 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively (time frame: Within 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.