Condition category
Surgery
Date applied
16/12/2003
Date assigned
22/12/2003
Last edited
26/06/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus W Büchler

ORCID ID

Contact details

University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
Markus_Buechler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KSC 02/2003

Study information

Scientific title

Acronym

CLIVIT-Trial

Study hypothesis

To date, no clear scientific recommendation exists in regard to the available blood vessel ligation techniques in thyroid surgery. A systematic review comparing different blood vessel ligation techniques has not yet been performed. The literature on this topic shows several deficits thus reducing its internal and external validity. Main problems are underpowered sample sizes, missing data in regard to the surgical technique, lack of standardization of the various surgical techniques and of homogeneity of the used study designs.

Therefore a randomized controlled multicenter, patient-blinded, two-group parallel relevance study under standardized conditions is required in order to achieve high internal as well as external validity. This would allow the results to be generalized for thyroid surgery and also may have implications for other surgical settings. This study is one of the first studies designed and organized by the Study Center of the German Surgical Society (SDGC). Besides investigating the primary hypothesis, this study was also started with the aim of developing a nationwide structure for randomized trials using a common and surgical relevant procedure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Thyroid surgery

Intervention

The standard surgical approach in both treatment groups will be the Dunhill-Procedure which consists of a hemithyroidectomy and a subtotal thyroidectomy (at least 2/3 of the gland). The randomisation will proceed when the thyroid gland has been exposed and the decision in favour of a Dunhill procedure is made. Initially the vessels of the upper pole of the thyroid (hemithyroidectomy side) are localised and dissected from medial. Afterwards they are ligated with the conventional clamp-tie technique (Novafil 3-0 or equivalent monofilament suture type). Time is measured from ligating the vessels of the upper pole to the removal of the complete specimen. All vessels except the upper pole vessels of both sides are ligated according to the randomised technique: either using the clip vessel ligation technique or occluding manually by single ligatures (Vicryl 3-0).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The primary objective of this study is to test whether there is a relevant reduction in operating time (>15 min), using the clip vessel occluding technique versus the conventional clamp-tie.

Secondary outcome measures

Secondary objectives are divided into surgical and non-surgical categories. In the surgical category there are the following points: total duration of operation (skin incision until suture), weight of specimen, amount of postoperative bleeding, frequency of reoperation due to bleeding, recurrent laryngeal nerve paralysis (temporary or irreversible – pre- and postoperative assessment of vocal cord function by ENT-specialist), wound infection rate and rate of impaired parathyroid gland function. The non-surgical category consists of duration of postoperative hospital stay.

To assess the relevance of the chosen endpoints, the following ten aspects have to be ranked from "most important" to "least important" by patients and surgeons (only once): Intraoperative complications, postoperative complications, length of hospital stay, voice function, dysphagia, death, postoperative pain, postoperative fatigue, convalescence of complete physical maximum resilience and cosmetic result.

Overall trial start date

05/03/2004

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

The trial population consists of hospitalised patients of the four participating Departments of Surgery, who are planned for an elective thyroid operation. These operations can be performed with either the clip vessel ligation technique or the conventional clamp-tie technique.

At study enrollment:
• Age equal or greater than 18 years
• Expected survival time more than 12 months
• Patients with benign diseases of the thyroid gland scheduled for elective surgery
• Euthyroid metabolism (normal level of TSH or T3/T4)
• Normal function of the vocal cords
• Informed consent

At the end of surgical exploration:
• Suitable for at least 2/3 resection of the thyroid

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

420

Participant exclusion criteria

• Malignant disease or high suspicion for malignancy (clinical and imaging evidence)
• Nerve palsy
• Graves' Disease
• Coagulopathy
• Current immunosuppressive therapy
• Chemotherapy within 2 weeks before operation
• Radiotherapy completed no longer than 8 weeks before operation
• Severe psychiatric or neurologic disease
• Drug- and/or alcohol-abuse
• Participation in another intervention-trial with interference of intervention and outcome
• Inability to follow the instructions given by the investigator or the telephone interviewer
• Lack of compliance

Recruitment start date

05/03/2004

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Germany

Trial participating centre

University of Heidelberg Medical School
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg Medical School (Germany)

Sponsor details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
Markus_Buechler@med.uni-heidelberg.de

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Grant from the German Ministry of Research and Education and supported by the BBD-Aesculap© Company, Tuttlingen, Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 study design in http://www.ncbi.nlm.nih.gov/pubmed/16948853
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22729718

Publication citations

  1. Study design

    Seiler CM, Fröhlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, Deckert A, Witte S, Victor N, Buchler MW, Knaebel HP, Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery., Trials, 2006, 7, 27, doi: 10.1186/1745-6215-7-27.

  2. Results

    Diener MK, Seiler CM, von Frankenberg M, Rendel K, Schüle S, Maschuw K, Riedl S, Rückert JC, Eckmann C, Scharlau U, Ulrich A, Bruckner T, Knaebel HP, Rothmund M, Büchler MW, , Vascular clips versus ligatures in thyroid surgery--results of a multicenter randomized controlled trial (CLIVIT Trial)., Langenbecks Arch Surg, 2012, 397, 7, 1117-1126, doi: 10.1007/s00423-012-0976-y.

Additional files

Editorial Notes