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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Norway1 site
  • SorlandetHF Hospital

    Kristiansand, 4604

Other trials in Norway

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 groups in NCT01288599
Study groupRoleWhat they receive
Single port access laparoscopyExperimentalSingle port access laparoscopy for benign adnexal disease.
Receives: Procedure: Laparoscopic surgery
Conventional laparoscopyActive comparatorConventional 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.

  1. Postoperative pain

    Experienced pain over the last six hours measured on a VAS scale.

    Measured: 6 hours

Secondary outcomes (6)
  1. Satisfaction with cosmetic result

    Satisfaction with cosmetic result, self reported and based on the Manchester scar scale.

    Measured: 2 months postoperatively

  2. Operation time

    Operating time in minutes.

    Measured: 0 hours after the operation

  3. Blood loss

    Estimated blood loss in ml.

    Measured: 0 hours after the operation

  4. Complications

    Complications during surgery and late complications.

    Measured: Two months

  5. Shoulder tip pain

    Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.

    Measured: 24 hours

  6. 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.

  1. First posted2 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionSep 2011
  4. Study completionDec 2011

Resources

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)
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

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.

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