Surgical Procedure, UnspecifiedNCT05421117
Comparison of Laparoscopic Adnexal Mass Extraction Via the Transumbilical and Transvaginal Routes
An observational study of Surgical Procedure, Unspecified, run by Erzincan Military Hospital.
Trial summary
Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to minimize abdominal incisions and postoperative pain and to prevent incisional complications, such as incisional hernias and adhesions. Read more about this study
- Who is it for?
- Ages 16 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Laparoscopic adnexal mass extraction
- Type of treatment
- Surgery or procedure
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- 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 16 to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who underwent laparoscopic surgery for the removal of benign adnexal masses at three centers between January 2016 and December 2020 were examined retrospectively.
Who may be able to join
- -Women who underwent laparoscopic surgery for the removal of benign adnexal masses
Who cannot join
- -Patients with missing data about surgery information
About this study
Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to minimize abdominal incisions and postoperative pain and to prevent incisional complications, such as incisional hernias and adhesions. Compared with open procedures, MIS is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, umbilical, or vaginal route. Apart from these, mini laparoscopy can provide a better cosmetic result without additional operative time or complications. Despite the limited use of mini laparoscopy for gynecological procedures, its use has increased recently.
After excision, an adnexal mass can be removed through a laparoscopic (LS) port using a variety of endoscopic or containment bags. After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal. When a mass is large or cannot be removed through the port, the incision may be enlarged slightly. This situation may yield a cosmetically worse outcome and increases the risk of postoperative complications, such as adhesion, hernia, and increased postoperative pain. Thus, natural orifice surgery (NOS) has emerged for tissue removal in such cases.
This study was performed to compare the transumbilical (TU) and transvaginal (TV) routes for adnexal mass removal from the abdominal cavity
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Laparoscopic adnexal mass extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adnexal mass extractionProcedure or surgery
Compared with open procedures, Minimally invasive surgery (MIS) is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, trans umbilical (TU), or trans vaginal (TV) route.
| Study group | Role | What they receive |
|---|---|---|
| transumbilical (TU) routes | For the TU group, a surgical glove was created bag during the operation as follows: a sterile, surgical latex glove (size 8.5) was double tied at the level of the wrist, the fingers were removed, and a 75-cm purse-string suture was made using a symmetrical knot to form a bag. The glove bag took an average of 10 min to make. It was lubricated with normal saline to remove the talcum powder and then introduced through the 10-mm umbilical port (optic port). The fingers of the glove were removed to facilitate its insertion with the 10-mm trocar and for ease of movement in the abdominal cavity. Receives: Procedure: Laparoscopic adnexal mass extraction | |
| transvaginal (TV) routes | A curette was placed into the uterine cavity and stabilized with a tenaculum for manipulation of the uterus. After separation of the adnexal mass ligaments, the manipulator was removed to perform TV retrieval. A vaginal retractor was inserted into the vagina to view the cervix and allow removal of the mass via the TV route. The posterior lip of the cervix was grasped with an Allis forceps and then pulled superiorly to expose the posterior vaginal dome. The sampler was inserted into the vagina and pushed gently against the vaginal wall to define the posterior fornix between the uterosacral ligaments. A 1-2-cm transverse TV posterior colpotomy was performed under laparoscopic control using a 3-mm monopolar hook. The sample was pulled into the vagina by holding the bag mouth from the colpotomy with ring forceps. The bag mouth was opened in the vaginal canal and the sample was transferred from the vagina. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional pain score
Each patient was asked by the care nurse or assistant doctor to record the severity of incisional pain on a Visual Analogue Scale (0, no pain; 10, unbearable pain) 3 hours after surgery.
Measured: The time between the end of the surgery and 3 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Erzincan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421117
- Sponsor's protocol ID
- MUGLA-7
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Adnexal Mass Extraction Via the Transumbilical and Transvaginal Routes
- ClinicalTrials.gov ID
- NCT05421117
- Acronym / sponsor ID
- MUGLA-7
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Jun 2022 (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.
Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to minimize abdominal incisions and postoperative pain and to prevent incisional complications, such as incisional hernias and adhesions. Compared with open procedures, MIS is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, umbilical, or vaginal route. Apart from these, mini laparoscopy can provide a better cosmetic result without additional operative time or complications. Despite the limited use of mini laparoscopy for gynecological procedures, its use has increased recently.
After excision, an adnexal mass can be removed through a laparoscopic (LS) port using a variety of endoscopic or containment bags. After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal. When a mass is large or cannot be removed through the port, the incision may be enlarged slightly. This situation may yield a cosmetically worse outcome and increases the risk of postoperative complications, such as adhesion, hernia, and increased postoperative pain. Thus, natural orifice surgery (NOS) has emerged for tissue removal in such cases.
This study was performed to compare the transumbilical (TU) and transvaginal (TV) routes for adnexal mass removal from the abdominal cavity
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transumbilical (TU) routes | – | Procedure: Laparoscopic adnexal mass extractionFor the TU group, a surgical glove was created bag during the operation as follows: a sterile, surgical latex glove (size 8.5) was double tied at the level of the wrist, the fingers were removed, and a 75-cm purse-string suture was made using a symmetrical knot to form a bag. The glove bag took an average of 10 min to make. It was lubricated with normal saline to remove the talcum powder and then introduced through the 10-mm umbilical port (optic port). The fingers of the glove were removed to facilitate its insertion with the 10-mm trocar and for ease of movement in the abdominal cavity. |
| transvaginal (TV) routes | – | –A curette was placed into the uterine cavity and stabilized with a tenaculum for manipulation of the uterus. After separation of the adnexal mass ligaments, the manipulator was removed to perform TV retrieval. A vaginal retractor was inserted into the vagina to view the cervix and allow removal of the mass via the TV route. The posterior lip of the cervix was grasped with an Allis forceps and then pulled superiorly to expose the posterior vaginal dome. The sampler was inserted into the vagina and pushed gently against the vaginal wall to define the posterior fornix between the uterosacral ligaments. A 1-2-cm transverse TV posterior colpotomy was performed under laparoscopic control using a 3-mm monopolar hook. The sample was pulled into the vagina by holding the bag mouth from the colpotomy with ring forceps. The bag mouth was opened in the vaginal canal and the sample was transferred from the vagina. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who underwent laparoscopic surgery for the removal of benign adnexal masses at three centers between January 2016 and December 2020 were examined retrospectively.
Key inclusion criteria (1 listed)
- -Women who underwent laparoscopic surgery for the removal of benign adnexal masses
Key exclusion criteria (1 listed)
- -Patients with missing data about surgery information
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 |
|---|---|---|
| Laparoscopic adnexal mass extractionCompared with open procedures, Minimally invasive surgery (MIS) is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, trans umbilical (TU), or trans vaginal (TV) route. | Procedure or surgery | transumbilical (TU) routes |
Primary outcome
Incisional pain score
Time frame: The time between the end of the surgery and 3 hours after the operation
Each patient was asked by the care nurse or assistant doctor to record the severity of incisional pain on a Visual Analogue Scale (0, no pain; 10, unbearable pain) 3 hours after surgery.
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 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Surgical Procedure, Unspecified, run by Erzincan Military 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 1 inclusion and 1 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 16 Jun 2022. 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?
Incisional pain score (time frame: The time between the end of the surgery and 3 hours after the operation). 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 16 Jun 2022.