Ovarian CystPhase 3NCT01288599
Single Versus Conventional Laparoscopy for Benign Adnexal Disease
A Phase 3 study testing Laparoscopic surgery in people with Ovarian Cyst, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cyst
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years.
- ASA score 1 or 2.
- Presumed benign ovarian disease or a hereditary cancer risk.
- Ovarian cyst ≤ 6 cm.
Who cannot join
- Ovarian cyst > 6 cm.
- Endometrioma.
- Endometriosis.
- History of chronic pelvic pain.
- Known severe intra abdominal adhesions.
- Daily use of analgesics.
- Inability to understand Norwegian or English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.
Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference.
The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group.
Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.
Read the detailed description
Although there are many reports indicating that single port laparoscopy for benign adnexal disease is feasible, there have to date not been published any randomized studies proving a superior outcome compared to conventional laparoscopy.
Theoretically, there are several advantages with a single port access. Because only one incision is made in place of several, less postoperative pain could be expected. The incision made is slightly larger (2 cm) than the ones used in conventional laparoscopy. It could therefore be easier to evacuate carbon dioxide gas (CO2) out of the abdomen after the operation, resulting in less shoulder tip pain, which is a common discomfort postoperatively. Carbon dioxide gas is considered to be responsible for postoperative shoulder tip pain due to peritoneal stretching and diaphragmatic irritation (Alexander et al. 1987, Sarli et al. 2000). The better cosmetic result due to only one incision is apparent. If this improvement makes a different for the patients, is yet to be proven.
There might be fewer complications with single-port laparoscopy compared to conventional laparoscopy. As mentioned above, serious complications like bowel and vessel injury, mostly occurring when Verres needle or a trocar is introduced through the abdominal wall. By reducing the number of trocars introduced, these complications might occur less commonly.
Performing a randomized controlled trial will bring more knowledge to whether single port laparoscopy for benign adnexal disease will truly benefit the patients compared to the established operating method for this condition.
Surgical technique:
Preoperatively, all patients will be given paracetamol 1.5 grams, diclofenac 100 mg and oxycodone 10 mg as a single dose orally analgesics. Under general anaesthesia and endotracheal intubation the patient will be positioned in the dorsal lithotomy position with both legs supported in Allen stirrups and their arms resting alongside the body. An orogastric tube will be placed to decompress the stomach and a Foley catheter will be placed in the bladder.
In the single port laparoscopy group, 10 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected subcutaneously as local anaesthetic before a 2 cm vertical incision (measured with a sterile ruler) will be made through the umbilicus. The rectus fascia will be sharply incised and a single multiport trocar (Laparo-Endoscopic Single-Site Surgery, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be introduced via an introducer device in the peritoneal cavity. This port has an insufflation channel that allows carbon dioxide insufflation with the pressure set at 12 mm Hg. To obtain intrabdominal visualization, a 5-mm 30º telescope (EndoEye, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be used. A diagnostic peritoneal lavage will be performed. The patient will be placed in a Trendelenburg position. Curved hand instruments (HiQ LS, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be used to provide efficient retraction to optimize surgical exposure. A straight bipolar diathermy and scissors will be used to extirpate the cyst or remove the adnexa. After cystectomy or adnexectomy has been performed, the excised tissue will be removed through the multichannel port. Larger masses will be placed in 10-mm Endo Catch™ Gold (Covidien, Norwalk Connecticut, USA) to avoid spillage. If necessary, decompression of pelvic masses will be done with a 14-gauge angiocath needle at the umbilical incision after removal of the single port device. After removal of the tissue the multichannel access port will be opened to evacuate CO2. The port will be removed and the fascia will be sutured with Polysorb 0 suture. The skin will be closed using abrupt intracutaneous Polysorb 3-0 sutures.
In the conventional laparoscopy group, 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected as local anaesthetic before a 1 cm incision will be made in the umbilicus. Abdominal access will be gained by using an open entry technique. A suture will be placed in the fascia with Polysorb 0. Carbon dioxide will be insufflated through this port with a pressure set at 12 mm Hg. 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected at each of the places for three additional ports. Two 5-mm accessory Versaport™ Blade less trocars (Covidien, Norwalk Connecticut, USA) will be inserted in the lower right and left quadrant and a 12-mm Versaport™ Blade less trocar will be inserted in the midline, approximately 2 cm above the symphysis. Diagnostic peritoneal lavage will be performed. Cystectomy or adnexectomy will be performed using bipolar diathermy, scissors and a grasper. The tissue will be placed in 10-mm Endo Catch™ Gold (Covidien, Norwalk Connecticut, USA) and removed through the incision in the midline above the symphysis. If necessary, decompression of pelvic masses will be done with a 14-gauge angiocath needle and the skin incision would be extended to a maximum of 2 cm. The fascia in the midline incision above the symphysis will be sutured with Polysorb 0 using the Endoclose® hook (Covidien, Norwalk Connecticut, USA). The fascia in the umbilicus will be closed with the earlier placed suture and the skin in the midline incisions will be closed using abrupt intracutaneous Polysorb 3-0 sutures. The incisions in the right en left fossa will be closed using Steristrips™.
After the operation, the patients will receive analgesics on request. Their pain scores will be registered on a linear 10 cm visual analogue scale at 6 hours and 24 hours after the operation. They will also be asked if they experience shoulder tip pain. This pain will be registered after 6 hours and 24 hours. The use of analgesics while admitted at the hospital will be registered. They will be discharged from the hospital the first postoperative day. The patients will be contacted and asked about their use of analgesics for the next two days.
Two months after the operation, the patients will be asked to rate their satisfaction with the cosmetic result on a five point scale ranging from extremely unsatisfied to extremely satisfied. There will also be taken a picture of the scar in the umbilicus, which will be rated according to the Manchester scar scale (Beausang et al. 1998).
- Conditions
- Ovarian Cyst
- Being tested
- Laparoscopic surgery
- Keywords
- Laparoscopy, Randomized, Single port access, Adnexal disease, LESS
- Medical subject headings
- Ovarian Cysts, Adnexal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Laparoscopic surgery where adnexectomy or cystectomy is performed.
| Study group | Role | What they receive |
|---|---|---|
| Single port access laparoscopy | Experimental | Single port access laparoscopy for benign adnexal disease. Receives: Procedure: Laparoscopic surgery |
| Conventional laparoscopy | Active comparator | Conventional laparoscopy for benign adnexal disease. Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Experienced pain over the last six hours measured on a VAS scale.
Measured: 6 hours
Secondary outcomes (6)
Satisfaction with cosmetic result
Satisfaction with cosmetic result, self reported and based on the Manchester scar scale.
Measured: 2 months postoperatively
Operation time
Operating time in minutes.
Measured: 0 hours after the operation
Blood loss
Estimated blood loss in ml.
Measured: 0 hours after the operation
Complications
Complications during surgery and late complications.
Measured: Two months
Shoulder tip pain
Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.
Measured: 24 hours
Postoperative pain
Experienced pain over the last 24 hours measured on a VAS scale.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288599
- Sponsor's protocol ID
- Laparoscopy SSK
- Status last verified
- Feb 2011
- First submitted
- 18 Nov 2010
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoyer-Sorensen C, Vistad I, Ballard K. Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial. Fertil Steril. 2012 Oct;98(4):973-9. doi: 10.1016/j.fertnstert.2012.06.016. Epub 2012 Jul 4.
PubMed 22769732
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01288599
- Acronym / sponsor ID
- Laparoscopy SSK
- Conditions
- Ovarian Cyst
- Keywords
- Laparoscopy, Randomized, Single port access, Adnexal disease, LESS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Surrey
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Feb 2011 (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.
Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference.
The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group.
Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.
Detailed description
Although there are many reports indicating that single port laparoscopy for benign adnexal disease is feasible, there have to date not been published any randomized studies proving a superior outcome compared to conventional laparoscopy.
Theoretically, there are several advantages with a single port access. Because only one incision is made in place of several, less postoperative pain could be expected. The incision made is slightly larger (2 cm) than the ones used in conventional laparoscopy. It could therefore be easier to evacuate carbon dioxide gas (CO2) out of the abdomen after the operation, resulting in less shoulder tip pain, which is a common discomfort postoperatively. Carbon dioxide gas is considered to be responsible for postoperative shoulder tip pain due to peritoneal stretching and diaphragmatic irritation (Alexander et al. 1987, Sarli et al. 2000). The better cosmetic result due to only one incision is apparent. If this improvement makes a different for the patients, is yet to be proven.
There might be fewer complications with single-port laparoscopy compared to conventional laparoscopy. As mentioned above, serious complications like bowel and vessel injury, mostly occurring when Verres needle or a trocar is introduced through the abdominal wall. By reducing the number of trocars introduced, these complications might occur less commonly.
Performing a randomized controlled trial will bring more knowledge to whether single port laparoscopy for benign adnexal disease will truly benefit the patients compared to the established operating method for this condition.
Surgical technique:
Preoperatively, all patients will be given paracetamol 1.5 grams, diclofenac 100 mg and oxycodone 10 mg as a single dose orally analgesics. Under general anaesthesia and endotracheal intubation the patient will be positioned in the dorsal lithotomy position with both legs supported in Allen stirrups and their arms resting alongside the body. An orogastric tube will be placed to decompress the stomach and a Foley catheter will be placed in the bladder.
In the single port laparoscopy group, 10 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected subcutaneously as local anaesthetic before a 2 cm vertical incision (measured with a sterile ruler) will be made through the umbilicus. The rectus fascia will be sharply incised and a single multiport trocar (Laparo-Endoscopic Single-Site Surgery, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be introduced via an introducer device in the peritoneal cavity. This port has an insufflation channel that allows carbon dioxide insufflation with the pressure set at 12 mm Hg. To obtain intrabdominal visualization, a 5-mm 30º telescope (EndoEye, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be used. A diagnostic peritoneal lavage will be performed. The patient will be placed in a Trendelenburg position. Curved hand instruments (HiQ LS, Olympus Winter \& IBE GMBH, Hamburg, Germany) will be used to provide efficient retraction to optimize surgical exposure. A straight bipolar diathermy and scissors will be used to extirpate the cyst or remove the adnexa. After cystectomy or adnexectomy has been performed, the excised tissue will be removed through the multichannel port. Larger masses will be placed in 10-mm Endo Catch™ Gold (Covidien, Norwalk Connecticut, USA) to avoid spillage. If necessary, decompression of pelvic masses will be done with a 14-gauge angiocath needle at the umbilical incision after removal of the single port device. After removal of the tissue the multichannel access port will be opened to evacuate CO2. The port will be removed and the fascia will be sutured with Polysorb 0 suture. The skin will be closed using abrupt intracutaneous Polysorb 3-0 sutures.
In the conventional laparoscopy group, 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected as local anaesthetic before a 1 cm incision will be made in the umbilicus. Abdominal access will be gained by using an open entry technique. A suture will be placed in the fascia with Polysorb 0. Carbon dioxide will be insufflated through this port with a pressure set at 12 mm Hg. 5 ml of 0.5 % bupivacaine hydrochloride (Marcain®) will be injected at each of the places for three additional ports. Two 5-mm accessory Versaport™ Blade less trocars (Covidien, Norwalk Connecticut, USA) will be inserted in the lower right and left quadrant and a 12-mm Versaport™ Blade less trocar will be inserted in the midline, approximately 2 cm above the symphysis. Diagnostic peritoneal lavage will be performed. Cystectomy or adnexectomy will be performed using bipolar diathermy, scissors and a grasper. The tissue will be placed in 10-mm Endo Catch™ Gold (Covidien, Norwalk Connecticut, USA) and removed through the incision in the midline above the symphysis. If necessary, decompression of pelvic masses will be done with a 14-gauge angiocath needle and the skin incision would be extended to a maximum of 2 cm. The fascia in the midline incision above the symphysis will be sutured with Polysorb 0 using the Endoclose® hook (Covidien, Norwalk Connecticut, USA). The fascia in the umbilicus will be closed with the earlier placed suture and the skin in the midline incisions will be closed using abrupt intracutaneous Polysorb 3-0 sutures. The incisions in the right en left fossa will be closed using Steristrips™.
After the operation, the patients will receive analgesics on request. Their pain scores will be registered on a linear 10 cm visual analogue scale at 6 hours and 24 hours after the operation. They will also be asked if they experience shoulder tip pain. This pain will be registered after 6 hours and 24 hours. The use of analgesics while admitted at the hospital will be registered. They will be discharged from the hospital the first postoperative day. The patients will be contacted and asked about their use of analgesics for the next two days.
Two months after the operation, the patients will be asked to rate their satisfaction with the cosmetic result on a five point scale ranging from extremely unsatisfied to extremely satisfied. There will also be taken a picture of the scar in the umbilicus, which will be rated according to the Manchester scar scale (Beausang et al. 1998).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single port access laparoscopy | Experimental | Procedure: Laparoscopic surgerySingle port access laparoscopy for benign adnexal disease. |
| Conventional laparoscopy | Active comparator | Procedure: Laparoscopic surgeryConventional laparoscopy for benign adnexal disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women ≥ 18 years.
- ASA score 1 or 2.
- Presumed benign ovarian disease or a hereditary cancer risk.
- Ovarian cyst ≤ 6 cm.
Key exclusion criteria (7 listed)
- Ovarian cyst > 6 cm.
- Endometrioma.
- Endometriosis.
- History of chronic pelvic pain.
- Known severe intra abdominal adhesions.
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 surgeryLaparoscopic surgery where adnexectomy or cystectomy is performed. | Procedure or surgery | Conventional laparoscopy, Single port access laparoscopy |
Primary outcome
Postoperative pain
Time frame: 6 hours
Experienced pain over the last six hours measured on a VAS scale.
6 secondary outcomes
Satisfaction with cosmetic result
Time frame: 2 months postoperatively
Operation time
Time frame: 0 hours after the operation
Blood loss
Time frame: 0 hours after the operation
Complications
Time frame: Two months
Shoulder tip pain
Time frame: 24 hours
Postoperative pain
Time frame: 24 hours
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 Jul 2012.
- Derived from this study: PubMed 22769732Hoyer-Sorensen C, Vistad I, Ballard K. Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial. Fertil Steril. 2012 Oct;98(4):973-9. doi: 10.1016/j.fertnstert.2012.06.016. Epub 2012 Jul 4.
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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 Phase 3 study testing Laparoscopic surgery in people with Ovarian Cyst, run by Sorlandet Hospital HF at 1 site in Norway.
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 4 inclusion and 7 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 3 Jul 2012. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain (time frame: 6 hours). 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 NCT01288599, which also lists 1 linked publication.
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 Jul 2012.