Theca Lutein Cyst of Left OvarymesosalpinxNCT02513953
Case Report of Endometrioma in Layers of Broad Ligament.
A study testing Laparoscopic in people with Theca Lutein Cyst of Left Ovary, run by Ruby Hall IVF and Endoscopy Centre.
Trial summary
Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers of Broad Ligament. Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were performed in… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Theca Lutein Cyst of Left Ovary
- What is being tested?
- Laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2015
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Sub-fertile women with confirmed diagnosis of pelvic endometriosis.
-
Exclusion Criteria:women with Pelvic inflammatory disorders and other forms of benign cysts.
About this study
Official title: Endometrioma in Layers of Brot ad Ligament in Left Adnexa
Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers of Broad Ligament.
Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary and uterus was identified and excised by Four Port laparoscopic interventional surgery.
Read the detailed description
Endometriosis is the second most common finding in the pelvis of females in their reproductive age, frequently associated with primary infertility. Endometrioma, within layers of broad ligament has been reported, but only in four cases, so far.
Contributing factors in the etiopathogenesis of endometriosis and endometriomas are retrograde menstrual flow, metaplasia, genetic predisposition, lymphatic/ vascular distribution, immune dysfunction and environmental influences. Etiopathogenesis of endometriosis is still poorly understood, the main theories being embryonic, migratory and immunologic. Embryonic theories suggest that endometriosis develops from the remnants of wolffian ducts or the Mullerian ducts or may develop from the metaplasia of the peritoneal or the ovarian tissue. Migratory theories suggest transportation of endometrial tissue to distant places via fallopian tubes or, lymphovascular structure and subsequent implantation as the cause of endometriosis. Immunologic theory implies that altered immune response may help in ectopic endometrial implantation. However, all these mechanisms may act synergistically and not in exclusion of each other. Endometrial alterations in the eutopic endometrium have also been demonstrated in women with endometriosis. These alterations involve progesterone receptors co - activator, Hic - 5 resulting in resistance to progesterone. Endometriosis commonly involves ovaries, POD, uterosacral ligaments and rectovaginal septum, all within the pelvis. This accounts for the retrograde menstruation being the most popular theory of pathogenesis for endometriosis. But endometriosis may develop at many unusual locations incl. abdominal wall, urinary system, gastrointestinal system, thorax, inguinal canal, large muscular or in few cases, within the layers of broad ligament.
Endometriosis, within the layers of broad ligament presents with classical symptoms of pelvic endometriosis, triad of chronic pelvic pain, dysmenorrhea and dyspareunia. Our patient, under reporting, presented with throbbing pain in lower abdomen. Other descriptions of pain being gnawing pain or dragging pain to the legs. Compared to women with superficial endometriosis, those with deep disease are more likely to report dyschezia. All the four cases of endometriosis of broad ligament reported so far, had one or more of these symptoms, the most common being episodic or continuous in low abdomen. All these cases reported were 27 - 34yrs old. Although, endometriosis is strongly associated with infertility no association between broad ligament endometrioma and infertility has been reported so far. Previously reported cases have been either parous or nulliparous females not desirous of childbearing, our patient under reporting, is the first case being reported as a female presenting with subfertility. This association needs to be explored in future because apart from localized endometrioma, there were no other locations of endometriosis anywhere in the pelvis, in ovarian fossa, in POD or anywhere else. Could it be that implantation is the prerequisite in endometriomas causing infertility? Complete excision of cyst wall is preferred over drainage and ablation. The female patient was posted for operative laparoscopy in the post - menstrual period. Four port laparoscopy was preferred to visualize oblong cystic structure, measuring 4x3cms within the layers of left mesosalpinx. A small incision was applied on the most prominent part of the cyst on the posterior leaf of mesosalpinx and thick chocolate fluid was suctioned out. Cystectomy was performed, dissecting the cyst wall from the leaves of mesosalpinx, using harmonic. Posterior leaf of mesosalpinx was repaired with three interrupted sutures using vicryl no.1. Through peritoneal lavage with normal saline was given. Patient was discharged on the same day after uncomplicated post - operative period.
- Conditions
- Theca Lutein Cyst of Left Ovary
- Being tested
- Laparoscopic
- Keywords
- Endometriosis, Mesosalpinx, Broad Ligament, Laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopicProcedure or surgery
Also called cystectomy
Four Port Laparoscopic cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Experimental | Four port laparoscopy by way of intervention was needed for convenience in aspirating the cystic fluid and reversal of the cyst wall taking care not to destroy the normal ovarian tissue to minimize loss of ovarian reserve Receives: Procedure: Laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
cystectomy of endometrioma in layers of Broad Ligament
Laparoscopic surgery under general anaesthesia.
Measured: Forty five minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Theca Lutein Cyst of Left OvaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruby Hall IVF and Endoscopy Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parinazz Parhar, MBBS, Study chair, Ruby Hall Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513953
- Sponsor's protocol ID
- Endometriosis
- Acronym
- mesosalpinx
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrioma in Layers of Brot ad Ligament in Left Adnexa
- ClinicalTrials.gov ID
- NCT02513953
- Acronym / sponsor ID
- mesosalpinx / Endometriosis
- Conditions
- Theca Lutein Cyst of Left Ovary
- Keywords
- Endometriosis, Mesosalpinx, Broad Ligament, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ruby Hall IVF and Endoscopy CentreUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers of Broad Ligament.
Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary and uterus was identified and excised by Four Port laparoscopic interventional surgery.
Detailed description
Endometriosis is the second most common finding in the pelvis of females in their reproductive age, frequently associated with primary infertility. Endometrioma, within layers of broad ligament has been reported, but only in four cases, so far.
Contributing factors in the etiopathogenesis of endometriosis and endometriomas are retrograde menstrual flow, metaplasia, genetic predisposition, lymphatic/ vascular distribution, immune dysfunction and environmental influences. Etiopathogenesis of endometriosis is still poorly understood, the main theories being embryonic, migratory and immunologic. Embryonic theories suggest that endometriosis develops from the remnants of wolffian ducts or the Mullerian ducts or may develop from the metaplasia of the peritoneal or the ovarian tissue. Migratory theories suggest transportation of endometrial tissue to distant places via fallopian tubes or, lymphovascular structure and subsequent implantation as the cause of endometriosis. Immunologic theory implies that altered immune response may help in ectopic endometrial implantation. However, all these mechanisms may act synergistically and not in exclusion of each other. Endometrial alterations in the eutopic endometrium have also been demonstrated in women with endometriosis. These alterations involve progesterone receptors co - activator, Hic - 5 resulting in resistance to progesterone. Endometriosis commonly involves ovaries, POD, uterosacral ligaments and rectovaginal septum, all within the pelvis. This accounts for the retrograde menstruation being the most popular theory of pathogenesis for endometriosis. But endometriosis may develop at many unusual locations incl. abdominal wall, urinary system, gastrointestinal system, thorax, inguinal canal, large muscular or in few cases, within the layers of broad ligament.
Endometriosis, within the layers of broad ligament presents with classical symptoms of pelvic endometriosis, triad of chronic pelvic pain, dysmenorrhea and dyspareunia. Our patient, under reporting, presented with throbbing pain in lower abdomen. Other descriptions of pain being gnawing pain or dragging pain to the legs. Compared to women with superficial endometriosis, those with deep disease are more likely to report dyschezia. All the four cases of endometriosis of broad ligament reported so far, had one or more of these symptoms, the most common being episodic or continuous in low abdomen. All these cases reported were 27 - 34yrs old. Although, endometriosis is strongly associated with infertility no association between broad ligament endometrioma and infertility has been reported so far. Previously reported cases have been either parous or nulliparous females not desirous of childbearing, our patient under reporting, is the first case being reported as a female presenting with subfertility. This association needs to be explored in future because apart from localized endometrioma, there were no other locations of endometriosis anywhere in the pelvis, in ovarian fossa, in POD or anywhere else. Could it be that implantation is the prerequisite in endometriomas causing infertility? Complete excision of cyst wall is preferred over drainage and ablation. The female patient was posted for operative laparoscopy in the post - menstrual period. Four port laparoscopy was preferred to visualize oblong cystic structure, measuring 4x3cms within the layers of left mesosalpinx. A small incision was applied on the most prominent part of the cyst on the posterior leaf of mesosalpinx and thick chocolate fluid was suctioned out. Cystectomy was performed, dissecting the cyst wall from the leaves of mesosalpinx, using harmonic. Posterior leaf of mesosalpinx was repaired with three interrupted sutures using vicryl no.1. Through peritoneal lavage with normal saline was given. Patient was discharged on the same day after uncomplicated post - operative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | Experimental | Procedure: LaparoscopicFour port laparoscopy by way of intervention was needed for convenience in aspirating the cystic fluid and reversal of the cyst wall taking care not to destroy the normal ovarian tissue to minimize loss of ovarian reserve |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| LaparoscopicAlso: cystectomyFour Port Laparoscopic cystectomy | Procedure or surgery | Endometriosis |
Primary outcome
cystectomy of endometrioma in layers of Broad Ligament
Time frame: Forty five minutes.
Laparoscopic surgery under general anaesthesia.
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 3 Aug 2015.
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.
Parinazz Parhar, MBBS study chair
Ruby Hall Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic in people with Theca Lutein Cyst of Left Ovary, run by Ruby Hall IVF and Endoscopy Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Aug 2015. 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?
cystectomy of endometrioma in layers of Broad Ligament (time frame: Forty five minutes.). 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 3 Aug 2015.